Michael Christel

Today’s powerful convergence of health data and technology is fun to watch unfold, but a focused vision on system and process integration-and the framework for continuous enrichment-will be key to future lasting gains for clinical research.

Ambry Genetics' CEO discusses his company's decision to release the genetic information of its customers for free-a rare move, reportedly, for a commercial testing firm.

 This article originally appeared on Applied Clinical Trials.

Emerging technology partnerships in the biopharma space may be provide hope in accelerating patient enrollment, writes Michael Christel.

The concept of increasing the speed and efficiency of clinical trials is a well understood and agreed upon priority of most clinical operations professionals.

Pharm Exec speaks with IMS Health's John Daly and John Moran about new ways IDNs are impacting the healthcare decision landscape and the advantages of what they call “smart targeting”.

With drug-development efforts in Alzheimer’s disease continuing to produce underwhelming results-as clinicians have long battled the inherent diagnosis and translational research challenges associated with the disorder-it’s no secret that there is increased clinical focus now on the prevention and early detection of Alzheimer’s. Those were two areas of emphasis at the recent Alzheimer’s Association International Conference (AAIC) in Denmark. In fact, data presented at the event that reported a decline in incidence of dementia in the U.S. and Europe seems to indicate that reducing the risk of Alzheimer’s and even preventing the disease may be possible. Critical to those pursuits, however, will be future learnings generated from the growing recognition that treatment approaches in Alzheimer’s should target multiple pathologies. Joyce Suhy, Ph.D., VP of neuroscience at BioClinica Inc., a provider of medical imaging solutions for clinical trials, says that people who get dementia usually have mixed pathologies, whether it’s Alzheimer’s, Lewy body dementia, for example, or other similar neurodegenerative conditions. As evidence that researchers are focusing more on multiple pathologies, Suhy cites the recent collaboration struck between the Michael J. Fox Foundation for Parkinson’s Research and the Alzheimer’s Association and the W. Garfield Weston Foundation around studying the links between the Parkinson’s and Alzheimer’s patient populations, with the hopes of reshaping future treatment targets. For Alzheimer’s, specifically, Suhy and her team at BioClinica are focused on helping drugmakers determine whether patients in clinical trials targeting the build-up of amyloid plaque in the brain-considered a crucial factor in the onset of disease-actually have that pathological feature. Most of the notable prevention trials underway are testing drugs that target amyloid. In addition, Novartis recently partnered with Banner Alzheimer’s Institute (BAI) on a clinical study that will determine whether two Novartis experimental anti-amyloid drugs can prevent or delay the emergence of Alzheimer’s symptoms. Advanced molecular imaging techniques can aid in these efforts by ensuring a patient’s pathology is matched appropriately. Further, they provide clinical investigators with sophisticated tools to monitor Alzheimer’s in their studies. Suhy chaired a session on neuroimaging at AAIC, where BioClinica team members presented recent clinical trial progress using amyloid PET screening for enrichment of patient recruitment for early-stage Alzheimer’s. She notes that advances over the past decade in amyloid phenotyping, whether through PET scans or imaging of cerebrospinal fluid (CSF) flow, have helped to better target enrollment in Alzheimer’s trials, particularly as researchers are increasingly studying subjects with more prodromal and milder cognitive impairment. In its presentation, BioClinica reported higher amyloid-negative rates due to the inclusion of earlier-stage patients, when compared to historical trials, which focused more predominately on the mild-to-moderate Alzheimer’s population. “As we’re moving towards earlier screening for enrolling patients into Alzheimer’s disease trials, we find an increasing rate of patients that are amyloid-negative,” says Suhy. “Many of these patients may never advance to mild-to-moderate Alzheimer’s.” Uncovering these earlier clues can be valuable for drug developers when recruiting patients for Alzheimer’s treatment trials targeting amyloid. In past studies, otherwise qualified individuals-who turns out didn’t have amyloid clusters in their brains-were often enrolled, adding significant noise to those trials. The challenge, Suhy says, is that these subjects typically meet the various clinical criteria for the study protocol, such as memory or cognitive decline, and, therefore, are considered good candidates for enrollment. They often progress smoothly through the screening process, and only when getting a PET scan at the end is it discovered they are amyloid-negative. “If a patient doesn’t present with amyloid in the brain, then a drug targeting amyloid will not be effective,” says Suhy. “In other words, the drug target must be present in order for a drug to work. Hence, the current and important initiatives for screening clinical trial patients using molecular imaging like PET or CSF analysis to verify the presence of pathology and enroll appropriate patients for a trial.” Suhy points out that there are several ways to enrich Alzheimer’s patient populations to increase the chances of a successful trial. Besides PET or CSF imaging, some studies are looking at genotype ApoE 2, for example. “By identifying patients earlier in the course of disease, clinicians can maximize their ability to treat and ultimately help patients,” she says. “A key aspect to this is the identification and selection of the right patients.” Key takeaways AAIC, held in Copenhagen, Denmark’s capital city, featured more than 150 data unveilings in Alzheimer’s R&D. One particular notable development, according to Suhy, is the continued promise of tau PET tracers. Tau neurofibrillary tangles, like amyloid, represent one of the hallmark pathologic signs of Alzheimer’s. Though still early in testing, it is thought that tau is more closely linked to memory decline than amyloid, and, therefore, tau imaging-and the development of ligands for early detection of Alzheimer’s risk-may eventually be a better tool for determining cognitive impairment than amyloid imaging. Another takeaway for Suhy was the release of Phase II results for Genentech drug crenezumab, a monoclonal antibody that target all forms of amyloid beta. Though crenezumab did not meet its primary endpoints for cognition and function, a secondary analysis showed promising cognition effects in the milder Alzheimer’s patient cohort when taken at a higher dose. Suhy believes this data further reinforces the importance of early screening of disease risk.

To say that Susanne Heinzinger’s career trajectory has taken her from one spectrum of the healthcare arena to another may be an understatement. Before entering the pharmaceutical industry as a sales person, Heinzinger, who earned a Bachelor of Business Administration degree in accounting, worked as an auditor; she picked the job of auditing hospitals and home healthcare companies, mainly because she had always had an interest in the healthcare industry.

By the middle of 2015, global healthcare giant Baxter International Inc. is expected to officially split off its BioScience business, establishing the unit as an independent, innovation-focused biotechnology company.

The Physicians Payment Sunshine Act, more formally referred to as Open Payments, has been in place for almost 18 months. It is only in the next few months, however, that the implications of the law and its contentious requirements will start to be fully realised. Michael Christel reports.

The potential of comparative effective research in transforming healthcare remains untapped, but the opportunities are there, writes Michael Christel.

While at DIA’s 50th Annual Meeting, we got the chance to speak with Nancy Dreyer, chief of scientific affairs and senior VP at Quintiles Outcome, the CRO’s real-world and late-phase research division, about the current tide for comparative effectiveness research (CER).

In our final Q&A installment previewing next week’s iPharma2014 digital forum.

It’s no secret that the use of digital marketing in the life sciences industry has evolved considerably in recent years. The tools and strategies necessary for pharma brand teams to effectively engage with an increasingly more educated and informed consumer pool are seemingly advancing, or at least being modified, regularly.

Amid the looming March 31 deadline for remaining uninsured and underinsured Americans to purchase health insurance mandated by the Affordable Care Act (6 million newly Medicaid-eligible individuals are expected to enroll), pharmaceutical manufacturers and other key players in this space are emphasizing the importance of enhancing access to medications for the now rapidly expanding patient base.